# K023889: Wiener Lab. Chagatest Elisa Recomninante V.3.0, Model 96 Tests Cat. NR. 1203254

- Pathway: 510(k) (Traditional)
- Applicant: Wiener Laboratories Saic
- Decided: Feb 11, 2004 after 447 days
- Product code: MIU (Enzyme Linked Immunosorbent Assay, T. Cruzi)
- Device class: 1
- Regulation: 21 CFR 866.3870
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MERIDIAN Chagas' IgG ELISA: named in the summary without a submission number
- (no number) ABBOTT Chagas Antibody EIA test system: named in the summary without a submission number

## Most influential descendants
- K072732: Ortho T. Cruzi Elisa Test System (2009), 0 descendants of its own

## Recalls of this device
- Nov 10, 2017 · Class II · Z-0924-2018: Internal program testing shows that product may not reach the indicated expiration date.

## Indications for use
The Wiener Laboratory enzyme-linked Immunosorbent assay (ELISA) recombinante V. 3.0 test system is a manual and automated (using the Biochem Immunosystems, Inc Labotech instrument) assay for the qualitative detection of total antibodies (IgG and IgM) to Trypanosoma cruzi in human serum and plasma (EDTA, heparin, or Citrate) using recombinant antigens of T. cruzi. Reactive assay results are presumptive evidence of present or past infection with Trypanosoma cruzi.

Source page: https://510kreport.com/device/K023889
Methodology: https://510kreport.com/methodology